MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) PS210-030S-LIGHT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PS210-030S-LIGHT
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis summary: complaint confirmed: upon receiving the device, the blade had eschar buildup.The tip was soaked, and the device was decontaminated to continue with the analysis.Observing the device, it was noticed the heat shrink tore from both sides from the shoulder and the coating on the tip was worn off from being used during a total shoulder surgery.Duration of surgery or use of the disposable was not provided.Observing the blade, the clear and enamel coating were all worn off but does not show any indications of the coating peeling or chipped off.Before the blade was gently cleaned, the worn blade was not able to be seen until after the blade was soaked and cleaned.The coating was worn due to normal wear and tear.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a manufacture representative (rep) regarding a generator and a handpiece.It was reported that after the case, the doctor noted peeling of the coating of the blade at the distal tip.There was no patient harm.

• Brand Name: PS210-030S-LIGHT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• MDR Report Key: 11253199
• Report Number: 1226420-2021-00032
• Device Sequence Number: 3977715
• Product Code: GEI
• UDI-Device Identifier: 00763000279172
• UDI-Public: 00763000279172
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K193529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: PS210-030S-LIGHT
• Device Catalogue Number: PS210-030S-LIGHT
• Device Lot Number: 2005044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 118